Skip to main content
Premium Trial:

Request an Annual Quote

SigTuple Nabs FDA 510(k) Clearance for Pathology Sample Imaging

NEW YORK – Aria Diagnostics and SigTuple Technologies said Tuesday that the US Food and Drug Administration has granted 510(k) marketing clearance for SigTuple's artificial intelligence-assisted instrument to automate digitization of peripheral blood smear samples.

Indian AI and automation firm SigTuple's AI100 with Shonit instrument is used to automate sample scanning and cell categorization during slide digitization. Indianapolis-based Aria provided the central laboratory facilities for patient testing and platform validation testing of the instrument. The firms also partnered with Maryland-based consulting firm FDAMap, which provided project administration and management.

Aria President Vipin Adhlakha said in a statement that the AI100 with Shonit instrument automates one of the last remaining manual processes in the clinical review of pathology samples, improves lab workflow, enables remote pathology review, and expedites disease detection and diagnosis.

SigTuple Chief Product Officer Apurv Manjrekar said the collaboration "reinforces our commitment to transforming healthcare by harnessing the power of artificial intelligence," and AI100 with Shonit will help make diagnostic results more accessible, efficient, and reliable.